BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALCON ACS BIOSORB SUTURE 6-0

    MDR report key: 807250 · Received January 19, 2007

    Report

    Report Number
    MW1041675
    Event Type
    Other
    Date Received
    January 19, 2007
    Date of Event
    December 15, 2006
    Report Date
    January 19, 2007
    Manufacturer
    ALCON LABORATORIES
    Product Code
    GAR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ALCON ACS BIOSORB ABSORBABLE SUTURE 6-0 SIZE. ITEM NUMBER 10380658631-14, LOT NUMBER E4J0382. I HAVE USED THIS SUTURE SINCE IT CAME TO MARKET - OVER 7 YRS - , FOR THE PERFORMANCE OF ALL TYPES OF EYE MUSCLE SURGERY. IN THE PAST FEW WEEKS (SINCE OPENING A NEW BOX) I HAVE HAD MULTIPLE PTS WITH INTRAOPERATIVE EVIDENCE OF SUTURE STRETCHING REQUIRING MULTIPLE RE-TIES. THIS PARTICULAR PT UNDERWENT A VERY SMALL RESECTION OF ONE RECTUS MUSCLE WHICH DOES NOT NORMALLY CAUSE MUCH SUTURE TENSION, AND SHE HAD AN ADD'L SUTURING TECHNIQUE FOR REINFORCEMENT KNOWN AS A "CENTRAL SAG" BITE ALTHOUGH THERE WAS NO CENTRAL SAG. AFTER SUBSEQUENT NORMAL SURGICAL MANEUVERS IT WAS NOTED THAT ALL 3 STRANDS OF SUTURE BETWEEN THE MUSCLE AND SCLERA HAD LENGTHENED, WERE VISIBLY ATTENUATED, AND THE MUSCLE WAS HANGING BACK ABOUT 1 MM FROM ITS INTENDED LOCATION. I WILL REPORT THE OTHER PTS SEPARATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON ACS BIOSORB SUTURE 6-0 * GAR ALCON LABORATORIES * E4J0382

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other